Cardiovascular Risk FactorARxNCT07096167
Afterschool Rx 2.0: Prescriptions to Afterschool Care for Pediatric Cardiovascular Risk Reduction
A study testing Voucher for Afterschool Care in people with Cardiovascular Risk Factor, run by Augusta University.
Trial summary
The goal of this clinical trial is to learn if "prescribing" afterschool care to children at risk for poor heart health later in life increases their physical activity and improves their heart health. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Voucher for Afterschool Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A child must be entering 1st-4th grade when recruited (i.e., 5-11 years old)
- A child must have one or more cardiovascular risk factors as identified by a clinical care provider (i.e., obesity, hypertension, hyperglycemia, hyperlipidemia)
- Attend an elementary school patterned with a participating afterschool program
- Belong to a family at or below 250% of the federal poverty level
- The participating parent/guardian must have a phone that accepts text messages
Who cannot join
- If the child does not meet the inclusion criteria for attending the participating afterschool programs (e.g., children that require specially trained staff to safely provide care),
- If the child is pregnant
- If it is unsafe for the child to participate in any of the study measures as determined by their clinical care provider (i.e., can not safely complete a 6-min walk test or finger stick)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Advancing Pediatric Cardiovascular Health Through Afterschool Care: A Preliminary Randomized Controlled Trial
The goal of this clinical trial is to learn if "prescribing" afterschool care to children at risk for poor heart health later in life increases their physical activity and improves their heart health. 'Prescriptions' will be provided by pediatricians at participating Federally Qualified Health Centers and vouchers to existing afterschool programs (e.g., YMCA, Boys and Girls Clubs) will be provided by the research study. The main questions this study aims to answer are:
Can afterschool care providers and health care providers easily offer and keep using the voucher program?
Read more
Will families use the voucher? Do they go to afterschool care regularly, and do the families who use them represent a wide range or backgrounds?
Does going to afterschool care help children be more physical activity?
Does going to afterschool care improve heart health?
Researchers will compare two randomly assigned time periods; one semester when families get the voucher and one semester where they do not. They will look at whether use of the afterschool care voucher leads to more physical activity and improved heart health.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Voucher for Afterschool Care
- Keywords
- cardiovascular, out-of-school time, afterschool care, pediatric, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voucher for Afterschool CareBehavioural
Intervention includes a voucher for afterschool care and enrollment assistance
| Study group | Role | What they receive |
|---|---|---|
| AB Group (Intervention in Fall) | Other | Voucher for afterschool care and enrollment assistance provided in the fall semester, no intervention is provided in the spring semester Receives: Behavioral: Voucher for Afterschool Care |
| BA Group (Intervention in Spring) | Other | No afterschool voucher or enrollment assistance provided in the fall semester but is provided in the spring semester Receives: Behavioral: Voucher for Afterschool Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of families who complete the study (RE-AIM: Individual Reach)
Study logs will be used to determine the proportion of families who complete the study. Participants are considered to have completed the study if they do not withdraw or drop out. A successful outcome will be considered if ≥80% of families in both groups are retained in the study and families in both sequences (AB/BA) are retained in the study at equivalent rates.
Measured: 9 months (end of spring semester)
Proportion of children who attend afterschool care during intervention allocation (RE-AIM: Individual Implementation)
Attendance records provided by afterschool care programs will be used to determine the proportion of children who attend afterschool care during intervention allocation. Success will be defined as ≥80% of children attend afterschool care during intervention assignment.
Measured: Baseline (beginning of fall semester) to 4 months (end of fall semester) and 5 months (beginning of spring semester) to 9 months (end of spring semester)
Proportion of families that express a desire to continue attending afterschool care after the study ends (RE-AIM: Potential Maintenance)
Qualitative interviews with families at the school year will be used to determine families' interest in continuing to utilize afterschool care. A successful outcome will be defined as ≥80% of families in both groups express a desire to continue attending afterschool care after study ends.
Measured: 9 months (end of spring semester)
Portion of clinics and clinicians that participate in prescribing afterschool care (REAIM: Setting-level Adoption)
Study records will be used to measure the proportion of clinics and clinicians that prescribe afterschool care to eligible children. A successful outcome will be defined as a referral rate of ≥60% eligible children.
Measured: Baseline (beginning of fall semester) , 5 months (beginning of spring semester)
Proportion of afterschool programs providing afterschool care to study participants (REAIM: Setting-level adoption)
Study records will be used to measure the proportion of afterschool programs that are able and willing to provide afterschool care to children participating in the study. A successful outcome will be defined as having at least 8 available spots across participating programs each year (i.e., able to meet recruitment goals).
Measured: Baseline (beginning of fall semester), 5 months (beginning of spring semester)
The number of days and daily hours participating afterschool programs opperate (REAIM: Setting-level Implementation)
Study records and random unannounced direct observation will be used to measure the number of days and daily hours the afterschool programs operate. A successful outcome will be defined as the afterschool programs being open and operational on days local elementary schools are open and operational and that the participating afterschool program follows preplanned schedule on ≥80% of observation days.
Measured: Baseline (beginning of fall semester) to 4 months (end of fall semester) , 5 months (beginning of spring semester) to 9 months (end of spring semester)
Secondary outcomes (4)
Average proportion of afterschool time (14:30-19:00) spent in moderate-to-vigorous physical activity during the intervention condition compared to comparison condition
An AX3 Axivity placed on children's non-dominate wrist will be used to collect minutes of afterschool time (14:30-19:00) spent in moderate-to-vigorous physical activity (data processed using Hildebrand thresholds).
Measured: Baseline (beginning of fall semester) to 4 months (end of fall semester) VS. 5 months (beginning of spring semester) to 9 months (end of spring semester)
Average proportion of afterschool time spent sedentary during the intervention condition compared to comparison condition
An AX3 Axivity placed on children's non-dominate wrist will be used to collect minutes of afterschool time (14:30-19:00) spent sedentary (data processed using Hildebrand thresholds).
Measured: Baseline (beginning of fall semester) to 4 months (end of fall semester) VS. 5 months (beginning of spring semester) to 9 months (end of spring semester)
Average duration of daily screen use during the intervention condition compared to comparison condition
Parent-reported minutes spent using a screen (e.g., phone, computer, television) collected via electronic daily diaries will be used to calculate average duration of daily screen use.
Measured: Baseline (beginning of fall semester) to 4 months (end of fall semester) VS. 5 months (beginning of spring semester) to 9 months (end of spring semester)
Average sleep midpoint during the intervention condition compared to comparison condition
Parent-reported sleep log and Ax3 Axivity on non-dominate wrist will be used to calculate the average time halfway between sleep onset and offset (hh:mm).
Measured: Baseline (beginning of fall semester) to 4 months (end of fall semester) VS. 5 months (beginning of spring semester) to 9 months (end of spring semester)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- ORBIT Phase IIb preliminary, randomized crossover trial
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Lauren von Klinggraeff, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096167
- Sponsor's protocol ID
- IRBNet ID 2316862
- Other IDs
- 25CDA1451733, Career Development Award
- Acronym
- ARx
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study documents including study protocols, data management procedures, and deidentified individual participate data will be made available on Open Science Framework (DOI 10.17605/OSF.IO/H7VBT).
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Pediatric Cardiovascular Health Through Afterschool Care: A Preliminary Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07096167
- Acronym / sponsor ID
- ARx / IRBNet ID 2316862
- Conditions
- Cardiovascular Risk Factor
- Keywords
- cardiovascular, out-of-school time, afterschool care, pediatric, physical activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Aug 2025 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if "prescribing" afterschool care to children at risk for poor heart health later in life increases their physical activity and improves their heart health. 'Prescriptions' will be provided by pediatricians at participating Federally Qualified Health Centers and vouchers to existing afterschool programs (e.g., YMCA, Boys and Girls Clubs) will be provided by the research study. The main questions this study aims to answer are:
Can afterschool care providers and health care providers easily offer and keep using the voucher program?
Will families use the voucher? Do they go to afterschool care regularly, and do the families who use them represent a wide range or backgrounds?
Does going to afterschool care help children be more physical activity?
Does going to afterschool care improve heart health?
Researchers will compare two randomly assigned time periods; one semester when families get the voucher and one semester where they do not. They will look at whether use of the afterschool care voucher leads to more physical activity and improved heart health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ORBIT Phase IIb preliminary, randomized crossover trial
| Arm | Type | Receives |
|---|---|---|
| AB Group (Intervention in Fall) | Other | Behavioral: Voucher for Afterschool CareVoucher for afterschool care and enrollment assistance provided in the fall semester, no intervention is provided in the spring semester |
| BA Group (Intervention in Spring) | Other | Behavioral: Voucher for Afterschool CareNo afterschool voucher or enrollment assistance provided in the fall semester but is provided in the spring semester |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- A child must be entering 1st-4th grade when recruited (i.e., 5-11 years old)
- A child must have one or more cardiovascular risk factors as identified by a clinical care provider (i.e., obesity, hypertension, hyperglycemia, hyperlipidemia)
- Attend an elementary school patterned with a participating afterschool program
- Belong to a family at or below 250% of the federal poverty level
- The participating parent/guardian must have a phone that accepts text messages
Key exclusion criteria (3 listed)
- If the child does not meet the inclusion criteria for attending the participating afterschool programs (e.g., children that require specially trained staff to safely provide care),
- If the child is pregnant
- If it is unsafe for the child to participate in any of the study measures as determined by their clinical care provider (i.e., can not safely complete a 6-min walk test or finger stick)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voucher for Afterschool CareIntervention includes a voucher for afterschool care and enrollment assistance | Behavioural | AB Group (Intervention in Fall), BA Group (Intervention in Spring) |
Primary outcome
Proportion of families who complete the study (RE-AIM: Individual Reach)
Time frame: 9 months (end of spring semester)
Study logs will be used to determine the proportion of families who complete the study. Participants are considered to have completed the study if they do not withdraw or drop out. A successful outcome will be considered if ≥80% of families in both groups are retained in the study and families in both sequences (AB/BA) are retained in the study at equivalent rates.
Proportion of children who attend afterschool care during intervention allocation (RE-AIM: Individual Implementation)
Time frame: Baseline (beginning of fall semester) to 4 months (end of fall semester) and 5 months (beginning of spring semester) to 9 months (end of spring semester)
Attendance records provided by afterschool care programs will be used to determine the proportion of children who attend afterschool care during intervention allocation. Success will be defined as ≥80% of children attend afterschool care during intervention assignment.
Proportion of families that express a desire to continue attending afterschool care after the study ends (RE-AIM: Potential Maintenance)
Time frame: 9 months (end of spring semester)
Qualitative interviews with families at the school year will be used to determine families' interest in continuing to utilize afterschool care. A successful outcome will be defined as ≥80% of families in both groups express a desire to continue attending afterschool care after study ends.
Portion of clinics and clinicians that participate in prescribing afterschool care (REAIM: Setting-level Adoption)
Time frame: Baseline (beginning of fall semester) , 5 months (beginning of spring semester)
Study records will be used to measure the proportion of clinics and clinicians that prescribe afterschool care to eligible children. A successful outcome will be defined as a referral rate of ≥60% eligible children.
Proportion of afterschool programs providing afterschool care to study participants (REAIM: Setting-level adoption)
Time frame: Baseline (beginning of fall semester), 5 months (beginning of spring semester)
Study records will be used to measure the proportion of afterschool programs that are able and willing to provide afterschool care to children participating in the study. A successful outcome will be defined as having at least 8 available spots across participating programs each year (i.e., able to meet recruitment goals).
The number of days and daily hours participating afterschool programs opperate (REAIM: Setting-level Implementation)
Time frame: Baseline (beginning of fall semester) to 4 months (end of fall semester) , 5 months (beginning of spring semester) to 9 months (end of spring semester)
Study records and random unannounced direct observation will be used to measure the number of days and daily hours the afterschool programs operate. A successful outcome will be defined as the afterschool programs being open and operational on days local elementary schools are open and operational and that the participating afterschool program follows preplanned schedule on ≥80% of observation days.
4 secondary outcomes
Average proportion of afterschool time (14:30-19:00) spent in moderate-to-vigorous physical activity during the intervention condition compared to comparison condition
Time frame: Baseline (beginning of fall semester) to 4 months (end of fall semester) VS. 5 months (beginning of spring semester) to 9 months (end of spring semester)
Average proportion of afterschool time spent sedentary during the intervention condition compared to comparison condition
Time frame: Baseline (beginning of fall semester) to 4 months (end of fall semester) VS. 5 months (beginning of spring semester) to 9 months (end of spring semester)
Average duration of daily screen use during the intervention condition compared to comparison condition
Time frame: Baseline (beginning of fall semester) to 4 months (end of fall semester) VS. 5 months (beginning of spring semester) to 9 months (end of spring semester)
Average sleep midpoint during the intervention condition compared to comparison condition
Time frame: Baseline (beginning of fall semester) to 4 months (end of fall semester) VS. 5 months (beginning of spring semester) to 9 months (end of spring semester)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: Yes. Study documents including study protocols, data management procedures, and deidentified individual participate data will be made available on Open Science Framework (DOI 10.17605/OSF.IO/H7VBT).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Voucher for Afterschool Care in people with Cardiovascular Risk Factor, run by Augusta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (803.602.4674, lvonklinggraeff@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of families who complete the study (RE-AIM: Individual Reach) (time frame: 9 months (end of spring semester)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.